Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062476
Company: STERISCIENCE SPECLTS
Company: STERISCIENCE SPECLTS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/21/1986 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/24/2021 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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08/18/2020 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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08/18/2020 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
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06/24/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |
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04/24/1996 | SUPPL-19 | Labeling |
Label is not available on this site. |
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03/04/1994 | SUPPL-17 | Labeling |
Label is not available on this site. |
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05/24/1995 | SUPPL-16 | Labeling |
Label is not available on this site. |
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01/11/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
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02/28/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
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04/28/1992 | SUPPL-12 | Labeling |
Label is not available on this site. |